Boston—Should nonsteroidal anti-inflammatory drugs (NSAIDs) be added to the regimen to help patients with type 2 diabetes achieve glycemic control?

A study led by researchers from Joslin Diabetes Center and Harvard Medical School sought to answer that question, using salsalate, a prodrug form of salicylate.

They reported in the Annals of Internal Medicine that salsalate reduced both A1c and fasting blood glucose levels at all study time points (4, 8, 12, 16, 24, 36, and 48 weeks). Additionally, the study found that salsalate reduced inflammation in the body, as measured by blood tests. Some significant downsides also were identified, however.

For the 48-week study at three private physician practices and 18 academic medical centers in the United States, researchers randomly assigned 146 patients with established type 2 diabetes and inadequate glycemic control to take salsalate 3.5 g/d along with current therapies. That group then was compared them to 140 adult patients administered placebo as well as current therapies.

Study subjects ranged in age from 18 to 75 years old with fasting glucose levels of 12.5 mmol/L or less (≤225 mg/dL) and hemoglobin A1c (HbA1c) levels of 7.0% to 9.5%.

Of the total group, 283 were analyzed for changes in hemoglobin A1C level, anti-inflammatory effects, and adverse events.

Results indicated that the average HbA1c level over 48 weeks was 0.37% lower in the salsalate group than in the placebo group (95% CI, –0.53% to –0.21%; P < 0.001).

“Glycemia improved despite more reductions in concomitant diabetes medications in salsalate recipients than in placebo recipients,” the report notes. “Lower circulating leukocyte, neutrophil, and lymphocyte counts show the anti-inflammatory effects of salsalate.”

While adiponectin and hematocrit levels increased more and fasting glucose, uric acid, and triglyceride levels decreased with salsalate, patients’ risk of hypoglycemia went up six-fold, compared to those getting the placebo. Other apparent downsides were increases in body weight and total and low-density lipoprotein cholesterol levels, as well as evidence of reduced kidney function that was reversed after salsalate was stopped.